Applicants Guide
for
Laboratories
PNAC
PAKISTAN
NATIONAL
ACCREDITATION
COUNCIL
Applicants Guide
For
Laboratories
F-01/03
Issue Date:21/09/07
Rev No: 03
Applicants Guide
for
Laboratories
F-01/03
Issue Date:21/09/07
Rev No: 03
Contents
1.
Introduction………………………………………………………………………… 3
2.
Application for Accreditation………………………………………………………
3.
Introduction to the Assessment Process …………………………………………… 4
4.
Assessment Team…….…………………………………………………………….
5
5.
Pre-Assessment………….………………………………………………………….
5
6.
The Scope of Accreditation ………………………………………………………..
6
7.
Summary of the Full Assessment procedure……………………………………..
7
8.
Opening meeting…………………………………………………………………… 8
9.
Observation of Laboratory at Work ………………………………………………
10.
Summary of Findings………………………………………………………………. 10
11.
Closing Meeting……………………………………………………………………. 11
12.
Post-Assessment……………………………………………………………………
12
13.
Surveillance and Re-assessment………………………………………………….
12
14.
Extensions to Accredited Scope……………………………………………………. 14
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Applicants Guide
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F-01/03
Issue Date:21/09/07
Rev No: 03
1.
INTRODUCTION
1.1
The following notes will help laboratories seeking accreditation for
their testing and/or calibration activities to understand the steps involved in PNAC's
assessment of their laboratories.
1.2
Before applying formally to PNAC, the applicant laboratory should be
familiar with the requirements of ISO/IEC 17025/ ISO 15189: General requirements
for the competence of testing and calibration laboratories/Medical LaboratoriesParticular requirements for quality & competence.
2.
APPLICATION FOR ACCREDITATION
2.1.
A preliminary meeting at the PNAC office is recommended for the
purposes of clarifying initial questions. Applicants will be supplied with an
information pack containing the following: Application Form [F-01/01]/ [F01/09]
 Current fee structure/ schedule [F-01/02]
 This applicants' guide for laboratories [F-01/03]
 Agreement between PNAC and an accredited laboratory
[F-01/04]
2.2
The application form [F-01/09] is to be completed and signed by the
applicant, and returned together with the following:
Application fee

Laboratory's Quality Manual and procedures for review by PNAC

Agreement between PNAC and an accredited laboratory
[F-01/04]
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3.
INTRODUCTION TO THE ASSESSMENT PROCESS
3.1
This publication [F-01/03] provides background information on the
PNAC Laboratory Accreditation activities. All laboratories seeking accreditation are
assessed for compliance with ISO/IEC 17025/ ISO 15189, PNAC regulations, and any
further requirements specified by PNAC from time to time. Accreditation is achieved
by formal assessments, and this publication provides general guidance on the conduct
of such assessments. It summarizes the administrative procedures followed by PNAC
leading up to an assessment, and describes in detail the various stages involved in an
assessment visit.
3.2
Assessment plays the central part in providing the evidence on which
offers of accreditation are made. PNAC assesses the competence of laboratories to
carryout defined calibrations/tests or types of calibration/test and, after accreditation,
monitors, by surveillance and re-assessment, the continuing maintenance of that
competence.
3.3
Each applicant laboratory provides PNAC with a copy of its Quality
Manual and procedures, in the Application Form [F-01/09], basic information on its
activities, equipment, facilities and staff.
3.4.
PNAC assessors then visit the laboratory to check that the laboratory's
quality system, as detailed in its quality documentation, is compliant with ISO/IEC
17025/ ISO 15189, is appropriate to its needs and is being followed by the staff
3.5
During such an assessment visit, the work of the laboratory is observed
and records examined to establish the competence of the laboratory to perform the
calibrations/tests for which accreditation is sought.
3.6
All information obtained before, during or after assessment, including
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the fact that a particular laboratory has applied for accreditation, or that an application
for accreditation has been deferred or rejected, is treated as strictly confidential by the
PNAC and its assessors.
4.
ASSESSMENT TEAM
4.1
On receipt of the Application Form, [F-01/09], the Laboratory
Quality Manual, procedures and the Applicant Fee, the case is referred to concerned
Director of PNAC.
4.2
The concerned Director of Laboratory Accreditation is responsible for
selecting the assessment team. Laboratories have the right to object to the
appointment of a particular Assessor or Technical Expert and, in such cases, PNAC
endeavor to offer an alternative. In the event that a suitable alternative cannot be
identified, or the grounds for objection are considered to be unreasonable, PNAC
reserves the right to use the assessor originally selected.
4.3
The concerned Director of Laboratory Accreditation sends the
Application Form, Quality Manual and any calibration/testing procedures supplied to
other Assessors (if necessary) for a detailed review of the documentation.
4.4
Following the detailed document review, the laboratory is advised of
the composition of the assessment team and the assessment fee that it must agree to
pay before the assessment takes place. An estimate of the likely annual fee after
accreditation is also provided (F-01/02 refers)
5.
PRE-ASSESSMENT
5.1
Provided the detailed documentation review is satisfactory, a pre-
assessment visit is carried out. This visit for which a fee is payable, is usually carried
out by the Lead Assessor alone.
5.2
The pre-assessment visit allows the Lead Assessor to discuss with the
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laboratory management any areas of the laboratory's quality system, quality manual
and operating procedures that appear not to be in compliance with PNAC
requirements. It also provides an opportunity for the Lead Assessor to discuss
technical requirements such as uncertainty of measurement and proficiency testing.
The laboratory may then carry out any corrective actions needed before the final
accreditation assessment takes place.
6.
THE SCOPE OF ACCREDITATION
6.1
It is PNAC policy to define the scope of a laboratory's accreditation as
precisely as possible. This ensures that clients are provided with an accurate and
unambiguous description of the range of calibrations/tests covered by a laboratory's
accreditation. Laboratories are therefore asked to specify, in detail, the types of
calibration/test for which accreditation is sought. They are required to list, on their
Application Form, the standard specifications or other methods or procedures relevant
to the calibrations or tests concerned and the major items of laboratory equipment
used.
6.2
The concerned Director of Laboratory Accreditation together with the
Lead Assessor (if different) will agree with the laboratory how the calibrations/tests
for which accreditation is sought will be defined on the scope that will be issued if
accreditation is to be offered.
6.3
For calibration, the types of calibration, the range of measurements and
the operators to be assessed will be provisionally agreed at the pre-assessment. During
assessment, and after examination of the results of measurements, the content of the
scope will be agreed with the laboratory. This will include confirmation of the
measurements to be accredited, the range of measurement, the uncertainty, and the
names of the Head of Laboratory, Deputy Head of Laboratory and the Approved
Signatories.
6.4.
For testing, every effort will have been made to reach agreement on the
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content of the scope before the assessment. This is important, not only in order to
avoid possible misunderstandings, but also to help the assessors to operate effectively,
concentrating their attention in those areas of activity appropriate to the scope of
accreditation. In some cases, as the assessment proceeds, it may become clear that the
laboratory is not really in a position to achieve accreditation in certain areas within the
originally agreed scope. In such cases the Lead Assessor may be able to suggest a
suitably reduced or redefined scope for which accreditation may be offered
7.
SUMMARY OF THE FULL ASSESSMENT PROCEDURE
7.1
Following pre-assessment and/or the detailed documentation review
and on the completion of any corrective actions required as a result of pre-assessment,
arrangements can be made for final assessment.
7.2.
The assessment visit begins with an opening meeting between the
assessment team and representatives of the laboratory. On some occasions the team
makes a brief tour of the facilities. This is followed by a discussion on the laboratory's
quality system documentation, including any documented in-house procedures, and
then by detailed observation of the laboratory at work, to determine whether or not it
meets the criteria. Each assessor will be accompanied by a member of the laboratory
staff nominated by the management and having responsibility for the particular
section of work being assessed. A particular assessor may, therefore, be accompanied
by several different members of staff in the course of his or her work.
7.3
The visit ends with a closing meeting between the assessors and the
laboratory representatives; at which each assessor presents his or her observations and
the Lead Assessor summarizes the findings of the team.
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8.
THE OPENING MEETING
8.1
This is held on arrival to enable the assessment team and the
laboratory's representatives to become acquainted, and to clear up any difficulties or
confusion about the purpose of the assessment and what is expected of the laboratory
during the visit. It is chaired by the Lead Assessor and should cover.
(a)
Introductions;
(b)
an explanation of the purpose of the assessment and the functions of
each assessor;
(c)
discussion of the range of calibration/testing covered by the
laboratory's application and how this should be defined in the
laboratory's scope of accreditation;
(d)
a review of the agreed assessment programme, and confirmation
that a representative of the laboratory has been assigned to
accompany each assessor;
(e)
an explanation of the role of tile laboratory's representatives in the
assessment, particularly in agreeing observations recorded on the
Detail Report forms concerning any apparent failures to comply
with requirements.
(f)
an explanation of what will happen at the closing meeting and
confirmation of the time and venue;
(g)
an assurance that all findings will be treated in strict confidence;
(h)
arrangements for providing an office, and any services needed by
the assessors, e.g. photocopying; computer, fax, phone etc;
(i)
confirmation of work hours, lunch breaks etc;
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(j)
an opportunity for the laboratory representatives to ask relevant
questions.
9.
OBSERVATION OF THE LABORATORY AT WORK
9.1
This, the most important part of the assessment, follows the Opening
Meeting and consists of the assessment team making on-the-spot observations of the
laboratory going about its normal business. Assessors need to form a general
impression of the laboratory's overall competence and, in particular, of the suitability
of the methods and equipment for the work in hand including the state of its
maintenance and calibration. They also need to assess the competence of the staff and
the effectiveness of the quality system in ensuring that errors or omissions do not
appear in recording, analysing and reporting results.
9.2
Assessors may select a specific calibration/test, whether it is currently
being performed or not, and ask to see the apparatus involved (and the manufacturer's
manuals), and establish its state of calibration. They may select items of work in
progress,
witness
measurements
and
examine
documentation
concerning
calibration/test items. They may trace back results from previously issued certificates
or reports to the original entries in the laboratory's notebooks or work sheets. Aspects
which require evidence from some other area of the laboratory before they can be
settled may be noted down for further investigation, or they may be referred to
another member of the assessment team dealing with the area concerned.
9.3
During calibration assessments, the assessor(s) will establish the
capability of the laboratory to make measurements according to the uncertainty
claimed for each parameter for which accreditation is being sought. The results
obtained by the laboratory in measurement audits will also be examined. To confirm
calibration personnel as approved operators it may be necessary to assess their
performance on specific calibrations at locations chosen by PNAC.
9.4
The object of assessment is to establish, by observation, whether the
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work of the laboratory is being carried out in accordance with ISO/IEC 17025/ ISO
15189 and PNAC regulations. Any observations made will be recorded and verified
and will be based on objective evidence. To secure the greatest possible measure of
agreement on the facts, assessors are provided with forms for making an agreed
record of any observation, which may indicate a failure to comply with the
requirements. These forms provide the objective evidence on which the Lead
Assessor's recommendations to PNAC will be based.
9.5
Reports are intended to contain only factual observations relating to
possib1e nonconformities with specific requirements of ISO/IEC 17025/ ISO 15189
and PNAC regulations. It is the responsibility of the Lead Assessor, aided by advice
from the assessment team, to allocate formal nonconformities and to categorize them
appropriately before completing a Summary Report. There will not, therefore,
normally be any attempt to designate nonconformities at the time of observation, nor
any attempt to indicate the classification of the nonconformities that may be assigned.
10.
SUMMARY OF FINDINGS
10.1
After the assessors have completed their individual assignments, they
will hold a private meeting at which they will summaries their individual findings on
copies of the Individual Assessor's Report form and contribute to a co-ordinates view
of the laboratory at work. At this stage, the Lead Assessor will complete a Summary
Report form taking into account his or her own findings and those of any other
assessors involved.
10.2
The Summary Report will record the assessors' findings, any matters
needing corrective action, and the Lead Assessor's recommendation to PNAC
Recommendations may be for unconditional acceptance, for acceptance to be deferred
until the nonconformities have been cleared, or for refusal. The Summary Report will
make it clear which of these is being made. PNAC Accreditation will be granted only
after PNAC has received evidence that all nonconformities have been closed. The
maximum period allowed for corrective action will be specified. The period allowed
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will not, except in very unusual circumstances, be more than three months. Normally
a period of one month would be regarded as reasonable for minor nonconformities.
10.3
Where the number or the seriousness of the nonconformities found is
such that the whole of the laboratory's quality system and organisation is
demonstrably inadequate, the Lead Assessor's recommendation will be that
accreditation is refused
11.
THE CLOSING MEETING
11.1
The purpose of the closing meeting is to enable the Lead Assessor to
present the laboratory management with a summary of the results of the assessment
and to inform the management of the recommendations that the Lead Assessor will
make to PNAC.
11.2
The closing meeting is chaired by the Lead Assessor who will:
(a) emphasise that, because the assessment did not cover every aspect
of the laboratory activities, it does not follow that none exist in
areas where none have been reported;
(b) explain the significance of the classification nonconformities.
(c) invite each assessor to summaries his or her findings;
(d) present his or her own findings as an individual assessor;
(e) present the summary, conclusions and recommendations,
(f) hand over the copies of assessment reports and non-conformity
reports for assessment visit (if any) for management to take
appropriate corrective actions;
(g) invite the laboratory to specify date by which any required
corrective actions will be implemented;
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(h) provide the laboratory with an opportunity to discuss the
assessment;
(i) obtain the signature of the Quality Management Representative or
authorized deputy on the assessment reports and non-conformity
reports for assessment visit (if any).
12.
POST ASSESSMENT
12.1
On receipt of evidence of satisfactory corrective action, or following a
further visit to check the implementation of corrective actions, concerned Director
submits the case before PNAC’s Laboratory Accreditation Committee (LAC). After
positive recommendations of LAC the case is submitted to Director General PNAC
for approval. On approval PNAC will offer accreditation for the agreed scope of
calibrations or tests. As soon as the laboratory agrees the terms of accreditation and
pays the license fee (F-01/02 refers) PNAC will formally grant accreditation and issue
the Accreditation Certificate and scope.
12.2
When a further visit has been required, the Assessor(s) will return to
look specifically at the clearance of the nonconformities. However, should some other
potential nonconformity observed, the Assessor will bring this to the attention of the
management.
12.3
If the LAC or Director General PNAC does not accept the
recommendations of Assessment Team then the laboratory will be required to take
further corrective actions in the highlighted areas.
13.
SURVEILLANCE AND RE-ASSESSMENT
13.1
Following accreditation, laboratories will be subject to surveillance
and reassessment visits. The purpose of periodic surveillance and re-assessment is to
determine whether or not a laboratory is continuing to comply with the ISO/IEC
17025/ ISO 15189, PNAC Regulations, and any other requirements specified by
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PNAC. The general approach described in the previous paragraphs will be followed
for the conduct of surveillance or re-assessment visits.
13.2
If it is found, during a surveillance or re-assessment visit that, since the
last visit, there have been significant changes of staff, equipment or range of services
available, these matters will be recorded. Assessors will check that the changes are
not such as to diminish the laboratory's capabilities or scope of accreditation and that
they have already been fully notified to PNAC.
13.3
A re-assessment visit will involve a comprehensive re-examination of
the laboratory's quality system and calibration/testing activities and will be similar in
format and detail to an initial assessment. The first surveillance visit may be carried
out six months after the date of accreditation. Subsequent surveillance visits are
carried out at yearly intervals.
13.4
A full re-assessment takes place three years after the date of
accreditation.
13.5
At the conclusion of a surveillance or re-assessment visit, the Lead
Assessor will make a recommendation to PNAC on the continuing accreditation of the
laboratory. Depending on the number and type of any non-conformity found the Lead
Assessor will recommend whether accreditation should be:
(a)
maintained unconditionally (this recommendation will only be
made when no nonconformities have been found);
(b)
maintained on the understanding that any non-conformities
found are cleared within a specified time period (usually one
month);
(c)
maintained, but for a reduced Scope of Accreditation;
(d)
suspended
until
the
laboratory
has
discharged
the
nonconformities within a specified time period (normally no
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more than three months). A recommendation that the
accreditation of a laboratory is suspended will almost certainly
require a further visit to confirm that the nonconformities have
been cleared.
(e)
terminated (a recommendation that accreditation be terminated
will involve the laboratory in having to make a new application
and undergoing a further full assessment if it wishes to have its
accreditation re-instated).
13.6
Suspension or termination of accreditation will only be recommended
if the whole of the laboratory's quality system and organisation is seriously out of
compliance with requirements.
14.
EXTENSIONS TO ACCREDITED SCOPE
Accredited laboratories may wish to add further tests / calibration to
extend the scope of their accreditation. Extensions to scope require a formal
application using the form provided by PNAC, and will be dealt with on a case to case
basis. The application will need to be accompanied by documentary evidence of
competence in relation to the relevant industrial and technical activities. Small
extensions to scope may be dealt with during a surveillance assessment. Significant
extensions will usually require an assessment visit. PNAC will advise the organization
of the steps required to gain approval for the extension.
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